Depression and ART Adherence in HIV+ Latinos

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Data were collected in a two-stage process from 10/21/2009 – 8/31/2011 at a publicly-funded community health clinic in El Paso, TX, on the U.S.-Mexico border.

Pre-assignment Details

Eligible participants were randomly assigned to the intervention or treatment as usual (TAU) control condition, both enhanced with the notification letter to provider. An external statistician had used a computerized random number generator to select random permuted blocks of four.

Arm/Group Title

Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

Arm/Group Description

CBT intervention for adherence and ...

Those randomized to the control con...

Arm/Group Description

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

Total of all reporting groups

Overall Number of Baseline Participants

20

20

40

Baseline Analysis Population Description

[Not Specified]

Baseline Analysis Population Description

[Not Specified]

Age, Categorical

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

20 participants

20 participants

40 participants

<=18 years

0

0.0%

0

0.0%

0

0.0%

Between 18 and 65 years

20

100.0%

20

100.0%

40

100.0%

>=65 years

0

0.0%

0

0.0%

0

0.0%

Age, Continuous

Mean (Standard Deviation)

Unit of measure: Years

Number Analyzed

20 participants

20 participants

40 participants

47.3
(10.7)

44.8
(10.7)

46
(10.6)

Sex: Female, Male

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

20 participants

20 participants

40 participants

Female

5

25.0%

6

30.0%

11

27.5%

Male

15

75.0%

14

70.0%

29

72.5%

Ethnicity (NIH/OMB)

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

20 participants

20 participants

40 participants

Hispanic or Latino

20

100.0%

20

100.0%

40

100.0%

Not Hispanic or Latino

0

0.0%

0

0.0%

0

0.0%

Unknown or Not Reported

0

0.0%

0

0.0%

0

0.0%

Beck Depression Inventory 1a
[1]

Mean (Standard Deviation)

Unit of measure: Units on a scale

Number Analyzed

20 participants

20 participants

40 participants

22
(9.2)

16.8
(6.3)

19.4
(8.2)

[1]

Measure Description: Self-reported depressive symptoms were assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression.

Visual Analog Scale 30-day Adherence
[1]

Mean (Standard Deviation)

Unit of measure: Percent of doses taken

Number Analyzed

20 participants

20 participants

40 participants

84.4
(24.4)

90.6
(11.1)

87.2
(19.5)

[1]

Measure Description: Self-reported adherence was assessed with the visual analog scale. This is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.

Electronic Drug Adherence Monitoring
[1]

Mean (Standard Deviation)

Unit of measure: Percent Adherence

Number Analyzed

20 participants

20 participants

40 participants

43.2
(43.5)

55.6
(47.6)

49.4
(40.6)

[1]

Measure Description: The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding the designated time of taking their medication.

Montgomery-Asberg Depression Rating Scale (MADRS)
[1]

Mean (Standard Deviation)

Unit of measure: Units on a scale

Number Analyzed

20 participants

20 participants

40 participants

25.1
(9.7)

22.1
(9.8)

23.6
(9.7)

[1]

Measure Description: The MADRS is a 10-item clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The scale was developed to capture current depressive symptoms within the past seven days. The areas covered include: apparent and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.

Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.

Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale.

Time Frame

MADRS and BDI-1a scores at 6 and 9-month follow-up

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

Arm/Group Description:

CBT intervention for adherence and ...

Those randomized to the control con...

Arm/Group Description:

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

Overall Number of Participants Analyzed

20

20

Mean (Standard Deviation)

Unit of Measure: Units on a scale

MADRS at 6-month follow-up

17.8
(12.2)

19.2
(11.2)

MADRS at 9-month follow-up

19.7
(12.7)

17.7
(12.9)

BDI-1a at 6-month follow-up

15.0
(7.4)

11.8
(7.0)

BDI-1a at 9-month follow-up

14.2
(7.0)

13.5
(9.0)

2.Secondary Outcome

Title

Self-Report Adherence

Description

Self-reported adherence was assessed with the visual analog scale (VAS...

Description

Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.

Time Frame

Self-reported adherence at 6 and 9-month follow-up

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

Arm/Group Description:

CBT intervention for adherence and ...

Those randomized to the control con...

Arm/Group Description:

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

Overall Number of Participants Analyzed

20

20

Mean (Standard Deviation)

Unit of Measure: Percent of all doses of medication taken

Self-report adherence at 6-month follow-up

92.6
(9.4)

86
(14.7)

Self-report adherence at 9-month follow-up

93.5
(9.0)

91.9
(7.7)

3.Secondary Outcome

Title

MedSignals Electronic Pill-box for Adherence

Description

The MedSignals electronic pill-box is a storage bin that allows partic...

Description

The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.

Time Frame

6 and 9 month follow-up adherence scores

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

Arm/Group Description:

CBT intervention for adherence and ...

Those randomized to the control con...

Arm/Group Description:

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.

All-Cause Mortality

Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

Serious Adverse Events Serious Adverse Events

Cognitive-Behavioral Therapy (CBT-AD)

Control-Standard Care

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/20 (0.00%)

0/20 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events